Innovative Biometric Services Offered by CRO’s Simply put, Biometrics would ideally refer to the technology of authentication of an individual’s using automatic verification of personal attributes, for instance hands, fingers, face, eyes and voice using prints, geometry and pattern identification and many others. However, the inhibitions with regards to fraudulent internet activities along with safety modifications by National governments have made biometrics take the center stage after years of being noted as one “possibly useful” technology. Eminent CRO’s in India have their own Biometrics team that are competent and assist in all Clinical trials phases. The service portfolios are generally used by the biotechnology, pharmaceutical, diagnostics, device and research organizations. These services comprise protocol writing, report writing and statistical analysis and equipped with advanced software’s such as SAS, S-Plus, SPSS, R, StatXact, PASS, nQuery, WinNonLin, Kinetica, SDMS and MedXview. . Furthermore, the CRO’s offer a comprehensive range of data management services in Phase I-IV Clinical Trials and bioequivalence. The agenda is to convert data into reliable and concise trial outputs in compliance with the regulatory rules. The Biometric services and team in CRO’s concentrates on expediating the regulatory submission process and lessens timelines through innovative thinking. It also has the capacity to handle multi-centric studies, for global as well as domestic needs in various therapeutic areas. Medical writing services in popular CRO’s comprise the following components:Database Programming CRF Design (paper & electronic) CRF Annotation Database Programming Validation Checks Metadata Repository Management Data Management Data Acquisition Data Reconciliation Discrepancy Management Medical Coding (MeDRA& WHODD) Database Lock Data Extraction for Reporting
Pharmacokinetic &Pharmacodynamic Studies Sampling Point Estimation Technical Document Review
PK/PD Query Resolution PK/PD Subject Matter Expert Pharmacokinetic support across study engagement
PK/PD Reporting SDMS Data Extraction PK Data Analysis PK Summary Reporting Biostatistics Randomization Sample size estimation Trial Design Inputs Statistical Analysis Plan Statistical Analysis Biostatistics Subject Matter Expert
Statistical Reporting TLF Programming CDISC Data Mapping (SDTM &ADaM) Clinical Data Repository Pooled Data Analysis & Reporting Safety (ADR) Reporting Patient Profiles & Data Cleaning Reporting Biometrics is beneficial both to candidates as well as testing sponsors. From the point of view of the testing sponsors it secures value of credentialing program by retaining the integrity of the testing process. It deters proxy setting with the help of a highly visible system. It also helps to secure intellectual property from proxy testers and is adaptable to changing international laws. With regards to the candidate point of view Biometrics help to enhance the overall testing experience faster and smoother. The candidate data is always kept secure. Read also on: Phase I Studies
Published on Feb 21, 2012
Simply put, Biometrics would ideally refer to the technology of authentication of an individuals using automatic verification of personal at...